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Modulated electro‑hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial

  • Authors:
    • Kidong Kim
    • Jae-Hoon Kim
    • Seung Cheol Kim
    • Yong Beom Kim
    • Byung-Ho Nam
    • Jae  Hong No
    • Hanbyoul Cho
    • Woong Ju
    • Dong Hoon Suh
    • Yun Hwan Kim
  • View Affiliations / Copyright

    Affiliations: Department of Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnami, Gyeonggi 13620, Republic of Korea, Department of Obstetrics and Gynecology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of Korea, Department of Obstetrics and Gynecology, Ewha Womans University Mokdong Hospital, Seoul 07985, Republic of Korea, Herings Co., Ltd., Seoul 06144, Republic of Korea, Department of Obstetrics and Gynecology, College of Medicine, Ewha Womans University, Seoul 03760, Republic of Korea
    Copyright: © Kim et al. This is an open access article distributed under the terms of Creative Commons Attribution License.
  • Article Number: 787
    |
    Published online on: May 21, 2021
       https://doi.org/10.3892/etm.2021.10219
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Abstract

The present study (KGOG 3030) aimed to evaluate the safety of modulated electro‑hyperthermia (mEHT) therapy with weekly administration of paclitaxel or cisplatin in female patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. A total of 12 patients were randomized into the paclitaxel or cisplatin arm at a 1:1 ratio. Patients received weekly administration of paclitaxel (70 mg/m2) or cisplatin (40 mg/m2) intravenously on days 1, 8 and 15, and underwent mEHT therapy for 1 h on days 1, 4, 8, 11, 15, 18, 21 and 24 for each 4‑week cycle. The primary endpoint was the occurrence of dose‑limiting toxicity (DLT). The secondary endpoints were treatment‑emergent adverse events (TEAEs), objective response rate, carbohydrate antigen 125 (CA125) response rate, progression‑free survival (PFS) and overall survival (OS). In total, 16 patients were recruited, but four patients dropped out. None of the 12 remaining patients (6 each in the two arms) experienced DLT. Overall, 0 and 4 grade 3 TEAEs (anemia, nausea, neutrophil count decreased and platelet count decreased) occurred in the paclitaxel and cisplatin arm, respectively. Furthermore, one confirmed partial response and two CA125 responses were observed in the cisplatin arm. The median PFS time in the paclitaxel and cisplatin arms was 3.0 months (range, 1.7‑4.6 months) and 6.8 months (range, 3.9‑11.8 months), respectively, while the median OS time was 11.5 months (range, 8.4‑28.8+ months) and not reached (range, 3.9‑38.5+ months), respectively. In conclusion, mEHT therapy with weekly paclitaxel or cisplatin appeared safe and warrants further investigation. The present trial was registered with www.clinicaltrials.gov on January 22, 2015 (trial registration no. NCT02344095).
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Copy and paste a formatted citation
Spandidos Publications style
Kim K, Kim J, Kim SC, Kim YB, Nam B, No JH, Cho H, Ju W, Suh DH, Kim YH, Kim YH, et al: Modulated electro‑hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial. Exp Ther Med 22: 787, 2021.
APA
Kim, K., Kim, J., Kim, S.C., Kim, Y.B., Nam, B., No, J.H. ... Kim, Y.H. (2021). Modulated electro‑hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial. Experimental and Therapeutic Medicine, 22, 787. https://doi.org/10.3892/etm.2021.10219
MLA
Kim, K., Kim, J., Kim, S. C., Kim, Y. B., Nam, B., No, J. H., Cho, H., Ju, W., Suh, D. H., Kim, Y. H."Modulated electro‑hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial". Experimental and Therapeutic Medicine 22.1 (2021): 787.
Chicago
Kim, K., Kim, J., Kim, S. C., Kim, Y. B., Nam, B., No, J. H., Cho, H., Ju, W., Suh, D. H., Kim, Y. H."Modulated electro‑hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial". Experimental and Therapeutic Medicine 22, no. 1 (2021): 787. https://doi.org/10.3892/etm.2021.10219
Copy and paste a formatted citation
x
Spandidos Publications style
Kim K, Kim J, Kim SC, Kim YB, Nam B, No JH, Cho H, Ju W, Suh DH, Kim YH, Kim YH, et al: Modulated electro‑hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial. Exp Ther Med 22: 787, 2021.
APA
Kim, K., Kim, J., Kim, S.C., Kim, Y.B., Nam, B., No, J.H. ... Kim, Y.H. (2021). Modulated electro‑hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial. Experimental and Therapeutic Medicine, 22, 787. https://doi.org/10.3892/etm.2021.10219
MLA
Kim, K., Kim, J., Kim, S. C., Kim, Y. B., Nam, B., No, J. H., Cho, H., Ju, W., Suh, D. H., Kim, Y. H."Modulated electro‑hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial". Experimental and Therapeutic Medicine 22.1 (2021): 787.
Chicago
Kim, K., Kim, J., Kim, S. C., Kim, Y. B., Nam, B., No, J. H., Cho, H., Ju, W., Suh, D. H., Kim, Y. H."Modulated electro‑hyperthermia with weekly paclitaxel or cisplatin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: The KGOG 3030 trial". Experimental and Therapeutic Medicine 22, no. 1 (2021): 787. https://doi.org/10.3892/etm.2021.10219
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